MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN PAIN MANAGEMENT PUMP; ELASTOMERIC HFR

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Tinnitus (2103); Numbness (2415); Taste Disorder (4422)

Event Type  Injury  

Event Description

Fill volume: unknown.Flow rate: unknown.Procedure: spine.Cathplace: unknown.Infusion start time: (b)(6) 2022.Infusion stop time: unknown.The patient reported, via the pain block pro app, that on day 3 [post-surgery] they experienced: nausea, new ringing in their ears and/or metallic taste, and numbness in their right leg.Additionally, the patient reported that the pain in their spine, pre-procedure was rated at 9.Three days post-surgery, on (b)(6) 2022, the patient rated the pain at the surgical site at a 4, whereas the day before, they rated the pain at the surgical site at an 8.The patient also noted that they had taken 3 prescription opioid pain pills the day before.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.

• Brand Name: UNKNOWN PAIN MANAGEMENT PUMP
• Type of Device: ELASTOMERIC HFR
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 14332546
• MDR Text Key: 291400620
• Report Number: 2026095-2022-00051
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Female